United States Pharmacovigilance Market 2025 | Growth Drivers, Trends & Market Forecast, Competitive Landscape & Investment Opportunities

Market Size and Growth

The Global Pharmacovigilance Market is expected to grow at a CAGR of 12.43% during the forecast period 2024-2031.

Key Development:

United States: Recent Industry Developments

✅ In July 2025, the FDA's Sentinel Initiative expanded to monitor data from over 100 million patients, enhancing real-time detection of adverse drug reactions (ADRs) across the U.S. healthcare system.

✅ In June 2025, the FDA issued new guidance on the use of artificial intelligence in regulatory decision-making, emphasizing risk-based considerations and methodologies for AI deployment in pharmacovigilance.

✅ In May 2025, the 38th Pharmacovigilance USA conference convened in Boston, bringing together industry leaders to discuss advancements in drug safety, including AI integration and digital signal detection.

Japan: Recent Industry Developments

✅ In August 2025, a report highlighted that Japan's PMDA had the shortest review times for new drugs, with half of the drugs submitted to the U.S. first, underscoring Japan's commitment to expediting drug development.

✅ In May 2025, the Japanese government approved amendments to the Pharmaceuticals and Medical Devices Act, introducing measures to improve the efficiency of pharmacy operations and promote the proper use of pharmaceuticals.

✅ In February 2025, the PMDA held a seminar focusing on enhancing pharmacovigilance regulatory systems in the post-marketing phase, involving stakeholders from academia and the pharmaceutical industry.

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Recent Mergers and Acquisitions:

United States: Recent M&A Activity

✅ In July 2025, Johnson & Johnson announced its acquisition of Intra-Cellular Therapies for $14.6 billion, aiming to expand its central nervous system (CNS) portfolio. This strategic move enhances J&J's capabilities in pharmacovigilance and drug safety monitoring within the CNS therapeutic area.

✅ In May 2025, Jazz Pharmaceuticals entered into a definitive agreement to acquire Chimerix for $935 million, focusing on oncology and immunotherapy. This acquisition is expected to bolster pharmacovigilance efforts related to cancer therapies.

✅ In March 2025, GSK announced its agreement to acquire biotech company IDRx for up to $1.2 billion, aiming to strengthen its oncology pipeline. This acquisition will likely necessitate enhanced pharmacovigilance strategies for the new oncology assets.

Japan: Recent M&A Activity

✅ In August 2025, Biocon Biologics completed the acquisition of Viatris' biosimilars portfolio for $3.34 billion. This strategic move enhances Biocon's presence in the biosimilars market, requiring robust pharmacovigilance systems to monitor the safety of these biologic products.

✅ In May 2025, Zydus Lifesciences acquired Amplitude Surgical, a French medical device company, for €256.8 million. While primarily a medical device acquisition, it underscores the growing importance of integrated pharmacovigilance across therapeutic areas.

✅ In February 2025, Suven Pharma merged with Cohance Lifesciences, consolidating their contract development and manufacturing organization (CDMO) capabilities. This merger may lead to enhanced pharmacovigilance practices through streamlined operations and data integration.

Key Players:

=> ArisGlobal, BioClinica, Capgemini, Cognizant, FMD K&L Inc., Foresight Group International AG, IBM Corporation, Wipro Limited, and IQVIA among others.

Growth Forecast Projected:

The Global Pharmacovigilance Market is anticipated to rise at a considerable rate during the forecast period, between 2024 and 2031. In 2023, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Pharmacovigilance Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

➥ By Service Provider: Contract Outsourcing, In-house

➥ By Type of Reporting: Intensified ADR Reporting, Spontaneous Reporting, Cohort Event Monitoring, Targeted Spontaneous Reporting, EHR Mining

➥ By Clinical Trial Phase: Preclinical, Phase I, Phase II, Phase III, Phase IV

➥ By End-User: Hospitals, Pharmaceutical Companies

Regional Analysis for Pharmacovigilance Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Pharmacovigilance producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Pharmacovigilance revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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FAQ

Q: What is the growth rate of the Pharmacovigilance Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 12.43% during the forecast period from 2024 to 2031.

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